RIA 2 BONE HARVESTING KIT 520MM STERILE

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D10 CONCOMITANT. CORRECTED: D4 PRIMARY UDI NUMBER. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PHOTO INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. PHOTOS WERE PROVIDED FOR REVIEW, HOWEVER THE PHOTOS ONLY SHOW PART AND LOT NUMBER AND NO OTHER OBSERVATION PERTAINING TO THE NATURE OF THE REPORTED EVENT COULD BE IDENTIFIED. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. AS THE DEVICE WAS NOT RETURNED, AND AS-RECEIVED CONDITION COULD NOT BE ASSESSED, A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE RIA 2 BONE HARVESTING KIT L520 WOULD HAVE NOT CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: MANUFACTURING LOCATION: PACKAGED, STERILIZED AND RELEASED BY: MONUMENT, MANUFACTURING DATE: 31-JAN-2028, EXPIRATION DATE: 02-MAR-2026, PART NUMBER: 03.404.000S, RIA 2 BONE HARVESTING KIT 520MM STERILE, LOT NUMBER: 157190P (STERILE), LOT QUANTITY: (B)(4). COMPONENT PART(S) REVIEWED: PART NUMBER: 03.404M012, RIA II REAM ROD/DR SHAFT SEAL, LOT NUMBER: 126516P, LOT QUANTITY: (B)(4), INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF CONFORMANCE SUPPLIED BY (B)(4) DATED 22-SEP-2025 WAS REVIEWED AND DETERMINED TO BE CONFORMING. INSPECTION SHEET, INCOMING FINAL INSPECTION, NS073695 REV A MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 03.404M010, RIA II MANIFOLD ASSEMBLY, LOT NUMBER: 103571P, LOT QUANTITY: (B)(4), INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, NS073694 REV E MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF CONFORMANCE SUPPLIED BY (B)(4) DATED 05-JAN-2026 WAS REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 03.404M014, IRRIGATION TUBING SET, LOT NUMBER: 143390P, LOT QUANTITY: (B)(4), INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, NS073691 REV A MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE SUPPLIED BY (B)(4) DATED 02-FEB-2026 WAS REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 03.404M015, SUCTION TUBING SET, LOT NUMBER: 153499P, LOT QUANTITY: (B)(4). INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE SUPPLIED BY (B)(4) DATED 09-FEB-2026 WAS REVIEWED AND DETERMINED TO BE CONFORMING. INSPECTION SHEET, INCOMING FINAL INSPECTION, NS073692 REV A MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 03.404M033, RIA II GRAFT FILTER, LOT NUMBER: 97890P3, LOT QUANTITY: (B)(4). INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, NS073696 REV D MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF CONFORMANCE SUPPLIED BY (B)(4) DATED 12-DEC-2025 WAS REVIEWED AND DETERMINED TO BE CONFORMING. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE WITH BATCH NUMBER 157190P. NO NONCONFORMITIES OR MANUFACTURING IRREGULARITIES HAVE IDENTIFIED RELATED TO THE COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE REAMER HEAD F/RIA 2 Ø13 BROKE OFF INTO THE PATIENT, AND NOT ALL FRAGMENTS WERE RETRIEVED. THE RIA 2 BONE HARVESTING KIT L520 ALSO BROKE, BUT ALL FRAGMENTS WERE RETRIEVED. THE DRIVE SHAFT F/RIA 2 L520 REQUIRED INSPECTION DUE TO CONTAMINATION, AND IT WAS UNCLEAR IF IT WAS BROKEN. THE EVENT DESCRIPTION INDICATES THAT THE REAMER HEAD F/RIA 2 Ø13 WAS EMBEDDED WITHIN THE PATIENT, WHILE THE RIA 2 BONE HARVESTING KIT L520 AND DRIVE SHAFT F/RIA 2 L520 WERE NOT ASSOCIATED WITH RETAINED FRAGMENTS. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR INVOLVEMENT FOR ANY OF THE DEVICES.